NCT07131462

Evaluation and Treatment of Crown Fractures Using the Modified Baysal Dental Trauma Index

Evaluation of Crown Fractures in Permanent Teeth Following Dental Trauma Using the Modified Baysal Dental Trauma Index and Clinical Follow-Up of Their Treatments

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 39 (estimated)
• Sponsor: Inonu University · Academic / Other
• Sex: All
• Age: 6 Years – 14 Years
• Healthy volunteers: Not accepted

Summary

This study will be conducted by the Department of Pediatric Dentistry, Faculty of Dentistry, İnönü University, with the aim of evaluating the treatment processes and follow-up responses of patients aged between 6 and 14 years who will present with crown fractures in their maxillary or mandibular permanent incisors. Written informed consent will be obtained from the parents of all participating patients. The research will be carried out using a prospective observational design. Initially, sociodemographic information as well as personal data such as the child's age and gender will be collected through a questionnaire designed for the parents. Additionally, trauma-related information-including the time, location, and cause of the injury-will be recorded in detail using a trauma assessment form developed for the study. Each patient will undergo clinical and radiographic evaluations, and treatment planning and follow-up will be carried out based on these findings.

Detailed description

The sample size was determined based on a statistical power analysis. This analysis was conducted with an effect size of w = 0.5, an alpha error probability of α = 0.05, and a power of 1 - β = 0.8. Calculations performed for two degrees of freedom (df = 2) yielded a total required sample size of 39 participants. Inclusion Criteria: Age between 6 and 14 years Presence of a traumatic dental injury in a permanent tooth Type of TDI classified as either complicated or uncomplicated crown fracture Consent to participate provided by the patient's legal guardian Exclusion Criteria: Patients outside the 6-14 age range or presenting for other reasons Patients with traumatic dental injuries other than crown fractures Types of Treatments Applied for Crown Fractures: Restoration with composite resin Vital pulp therapies Regeneration Root canal treatment Clinical Evaluation Criteria of Our Study: Presence of pain and percussion sensitivity was considered a failure. Presence of abscess and fistula was considered a failure. Repair of the restoration was not considered a failure. Teeth showing loss of vitality and gray discoloration due to necrosis were considered a failure. The treatment success was evaluated using the Periapical Index (PAI) on periapical radiographs obtained from patients included in the study during follow-up visits. Internal and external root resorption were considered failures. If the radiolucent area observed at the apex had developed or increased after treatment, it was considered a failure. Reduction of initial radiolucencies observed in baseline radiographs of patients at the start of treatment or in those presenting late was considered a success. Evaluation was performed according to the Periapical Index (PAI) described by Ørstavik et al. in 1986. Disruption in the continuity of the lamina dura was considered a failure, whereas formation and continued development of the lamina dura were considered a success. An increase in root length was considered a success. Calcification observed within the root canals was considered a failure. For immature traumatic teeth with an open apex at the start of treatment, continued and completed root maturation was considered a success.

Conditions

• Dental Trauma
• Crown Fractures
• Tooth Fractures

Interventions

Type	Name	Description
PROCEDURE	Direct Composite Restoration	Application of direct composite resin to restore the fractured crown of permanent incisors.
PROCEDURE	Cvek Pulpotomy	Partial pulpotomy (Cvek technique) will be performed for complicated crown fractures with vital pulp exposure. The goal is to maintain pulp vitality using biodentin.
PROCEDURE	Endodontic Treatment	Root canal treatment will be applied to teeth with necrotic pulp or extensive pulp exposure not suitable for vital pulp therapy. Procedures will follow standard endodontic protocols.
PROCEDURE	Pulp Capping	In cases of minimal pulp exposure, a direct pulp capping procedure will be performed using biocompatible materials such as calcium hydroxide to preserve pulp vitality.

Timeline

• Start date: 2023-01-01
• Primary completion: 2025-09-01
• Completion: 2025-09-01
• First posted: 2025-08-20
• Last updated: 2025-08-20

Locations

1 site across 1 country: Turkey (Türkiye)